Freedom of Information request on the number of Yellow Card reports for Bell’s Palsy over the past 3 years (FOI 21-750)
Published 27 April 2022
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3rd August 2021
FOI 21/750
Dear
Thank you for your enquiry dated the 8th July, where you requested information regarding the number of Yellow Card reports for Bell’s Palsy over the past 3 years.
When considering the provided spontaneous Adverse Drug Reaction (ADR) data, it is important to be aware of the following points:
• A reported reaction does not necessarily mean it has been caused by the drug or vaccine, only that the reporter had a suspicion it may have. The fact that symptoms occur after use of a drug or vaccine, and are reported via the Yellow Card scheme, does not in itself mean that they are proven to have been caused by the drug or vaccine. Underlying or concurrent illnesses may be responsible and such events can also be coincidental.
• It is also important to note that the number of reports received via the Yellow Card scheme does not directly equate to the number of people who suffer adverse reactions and therefore cannot be used to determine the incidence of a reaction. ADR reporting rates are influenced by the seriousness of ADRs, their ease of recognition, the extent of use of a particular drug or vaccine and may be stimulated by promotion and publicity about a drug or vaccine. Reporting tends to be highest for newly introduced medicines during the first one to two years on the market and then falls over time. For these reasons the above data should not be used as a basis for determining incidence of side effects. During assessment we take into account of the variable levels of reporting as part of our monitoring procedures
Please find table below showing the number of UK spontaneous suspect adverse drug reaction (ADR) reports of Bell’s palsy received per year.
| Year | Number of Reports Total | Number of Reports Where at Least One Suspect Drug is a Covid-19 Vaccine |
|---|---|---|
| 2018 | 15 | 0 |
| 2019 | 22 | 0 |
| 2020 | 19 | 7 |
| 01/01/2021 - 30/06/2021 | 784 | 776 |
| Total | 840 | 783 |
As I am sure you are aware the UK is currently undergoing its vaccine rollout for the coronavirus vaccines. One of the ADRs reported and under specific review is Bell’s Palsy. As Bell’s Palsy has been subject to increased promotion and publicity recently, we would expect to receive an increase in reporting. The MHRA continues to review cases reporting Bell’s Palsy and to analyse case reports against the number expected to occur by chance in the absence of vaccination (the ‘natural rate’). The number of reports of facial paralysis received so far is similar to the expected natural rate and does not currently suggest an increased risk following the vaccines. We will continue to monitor these events, including through evaluation of electronic healthcare record data. Further information can be found here: Coronavirus (COVID-19) vaccine adverse reactions - GOV.UK (www.gov.uk).
For more information on our approach to use of Yellow Card data during COVID-19 vaccine safety surveillance please refer to our Covid-19 surveillance strategy which can be accessed in the Report of the Commission on Human Medicines Expert Working Group on COVID-19 vaccine safety surveillance - GOV.UK (www.gov.uk)
We have in place a Yellow Card strategy that works to increase awareness, actively promote and make reporting to the scheme more accessible for everyone. Information leaflets provided at the time of vaccination or invitations to be vaccinated signpost individuals to the Coronavirus Yellow Card reporting site. In addition, we have run social media campaigns informing healthcare professionals and members of the public that reporting to the Coronavirus Yellow Card reporting site will enable the MHRA to rapidly identify new and emerging side effects. We have also issued a Drug Safety Update, a press release, and the general public have also been encouraged to report any suspected side effects to the vaccine to the MHRA via a Yellow Card on recent televised press briefings. More information about the Yellow Card scheme and the campaigns we have run can be found via the Yellow Card website. Since the launch of the national immunisation campaign the Yellow Card scheme has benefited from an increased spotlight and as such the MHRA has seen an increase in reports received for non Covid-19 related drugs and vaccines.
If you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date of this response; and can be addressed to this email address.
Yours sincerely, FOI Team Vigilance and Risk Management of Medicines Division